OPSITE FLEXIFIX 5CMX10M - Transparent film roll - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Transparent film roll

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More Product Details

Catalog Number

66000040

Brand Name

OPSITE FLEXIFIX 5CMX10M

Version/Model Number

66000040

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

b1ae9ee5-c7f0-481b-971e-cfb7221f8b0e

Public Version Date

December 04, 2020

Public Version Number

1

DI Record Publish Date

November 26, 2020

Additional Identifiers

Package DI Number

05000223415136

Quantity per Package

24

Contains DI Package

05000223411466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SMITH & NEPHEW MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 63
2 A medical device with a moderate to high risk that requires special controls. 126
U Unclassified 1